Label: HAND SANITIZER- isopropyl alcohol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 12094-4915-0 - Packager: Hayward Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 16, 2020
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unclassified Section
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerin (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
isopropyl alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12094-4915 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00003 mL in 100 mL FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.0001 mL in 100 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00005 mL in 100 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.00012 mL in 100 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.0001 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.09973 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) 23.32 mL in 100 mL .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.0001 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12094-4915-0 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/30/2020 Labeler - Hayward Laboratories Inc. (800195513) Establishment Name Address ID/FEI Business Operations Hayward Laboraotires Inc. 800195513 manufacture(12094-4915)
